Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm)

Role Summary

Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm) at Amgen. Manage and lead all aspects of a device assembly and packaging line, maintaining production in full cGMP compliance. Supervise and develop technicians while overseeing production equipment to ensure production schedules are completed.

Responsibilities

• Lead manufacturing operations on the production floor, including equipment setup, operation, and troubleshooting.
• Maintain machine uptime, clear faults, and resolve stoppages on automated equipment.
• Ensure safety and compliance procedures are followed at all times.
• Escalate concerns to management when safety, equipment, supply, or quality risks arise.
• Provide training to manufacturing staff on processes and equipment.
• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the floor.
• Collaborate with Quality, Engineering, and Manufacturing Support to resolve manufacturing events promptly.
• Support deviation triage and CAPA processes.
• Write, review, and revise controlled documentation (SOPs, MPs, forms, technical reports, etc.).
• Apply process, scientific, operational, and compliance knowledge to support operations.
• Champion lean transformation and operational excellence initiatives; drive continuous improvement.
• Participate in design, development, and implementation of manufacturing floor processes.
• Participate in commissioning, qualification, and validation activities for processes and equipment.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance in cross-functional teams.

Qualifications

• Basic Qualifications:
  • High school/GED + 4 years biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Associate’s + 2 years biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Bachelor’s + 6 months biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Master’s degree
• Preferred Qualifications:
  • Degree in Chemical Engineering, Industrial Engineering, or Life Sciences
  • Technical understanding of pharmaceutical/biotech packaging equipment and processes
  • Experience with cGMP
  • Ability to be flexible and manage change
  • Experience leading cross-functional teams
  • Experience managing multiple priorities in a fast-paced environment
  • Strong scientific/technical interactions with partner organizations (PD and F&E)
  • Experience in GMP tech support, GMP operations, process development, or scheduling
  • Experience with commissioning and qualification, NPI, cleaning validation, and PPQ
  • Ability to analyze and interpret technical data affecting operations
  • Lean manufacturing and operational excellence background
  • Experience with manufacturing systems (MES, LIMS, Maximo, CCMS, SAP, etc.)

Skills

• Technical troubleshooting of production equipment and automation
• Process documentation and SOP/MP creation and revision
• Cross-functional collaboration
• Lean and continuous improvement methodologies
• Strong analytical and data interpretation skills

Education

• As listed in Qualifications: advanced degrees preferred depending on role

Additional Requirements

• None beyond qualifications listed; travel or physical demands not specified as essential